The present invention relates to catheters, and in particular, to a balloon-bearing single lumen catheter for injecting diagnostic fluids into a body cavity and a catheter apparatus employing same.
Diagnostic procedures which require a non-surgical entry into the uterus are well known. One such procedure known as hysterosalpingography, is a radiographic method for imaging the anatomical structures of the uterus and fallopian tubes. Hysterosalpingography involves inserting a fine flexible catheter through the cervical canal and injecting a contrast medium, such as an iodinated fluid, into the uterus. Radiography is then carried out to provide imaging information pertaining to the subject uterus.
Another well known diagnostic procedure which entails the non-surgical entry into the uterus is called hysterosonography. This procedure also employs a fine flexible catheter that is inserted into the cervical canal of the uterus. The catheter in this procedure enables the physician or technician to inject a sterile saline solution into the uterus to expand it so that an ultrasound scanner can be used to sonographically observe the uterus.
The catheters used in both procedures typically have means for sealing off the uterus after injection of the fluid to prevent backflow into the vaginal canal. One such means includes an inflatable intrauterine balloon made from an elastomeric material disposed adjacent the distal tip of the catheter. The catheter includes a first lumen that communicates with the interior of the balloon to enable inflation and deflation with an inflation syringe, and second lumen that is open at the distal tip of the catheter to enable injection of a desired diagnostic fluid into the uterus with a injection syringe.
The balloon catheter is operated by inserting the distal tip thereof through the cervical canal and into the uterus with the intrauterine balloon deflated. The insertion of the distal tip operates to position the deflated intrauterine balloon in the uterus or cervical canal. Once positioned, the inflation syringe is used to inflate the intrauterine balloon with air to seal block the cervical canal and the injection syringe is used to inject the desired diagnostic fluid into the uterus.
One problem associated with balloon catheters of this design is that they are relatively expensive to manufacture because they include two lumens and double syringes. Therefore, a less expensive balloon-bearing catheter is needed.
A catheter used for non-surgically entry into a uterus to dispense a diagnostic fluid therein; the catheter comprising a tubular body having a lumen extending from a first end thereof to a second end thereof. The lumen includes an external opening adjacent the first end for dispensing a diagnostic fluid into the interior of a subject uterus, and a balloon disposed marginally adjacent to the first end of the body for fluid sealing the interior of the subject uterus. The lumen further includes a second opening in fluid communication with the interior of the balloon for inflation thereof with the diagnostic fluid.
The catheter is typically combined with a syringe to form a catheter apparatus if desired.